Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2026-01-23 @ 7:48 PM
Study NCT ID:
NCT02738034
Status:
COMPLETED
Last Update Posted:
2021-11-17
First Post:
2016-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cogmed Training Effect in Hypertensive Patients With Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-16', 'studyFirstSubmitDate': '2016-03-23', 'studyFirstSubmitQcDate': '2016-04-13', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Medication adherence score', 'timeFrame': '10 weeks', 'description': 'Short version of Morinsk Questionnaire'}, {'measure': 'Quality of life score', 'timeFrame': '10 weeks', 'description': 'Whoqol'}, {'measure': 'Perceived Stress score', 'timeFrame': '10 weeks', 'description': 'PSS14'}, {'measure': 'Anxiety and Depression symptoms score', 'timeFrame': '10 weeks', 'description': 'BAI and BDI questionnaires'}], 'primaryOutcomes': [{'measure': 'Working memory score', 'timeFrame': '10 weeks', 'description': 'Backward Digits Test / Letter-Number Sequencing (WAIS-III): total score (sum of right answers)'}], 'secondaryOutcomes': [{'measure': 'Brain function', 'timeFrame': '10 weeks', 'description': 'Functional magnetic resonance'}, {'measure': 'Executive functions score', 'timeFrame': '10 weeks', 'description': 'Stroop test, Wisconsin Card Sorting Test, Frontal Assessment Battery and Controlled Oral Word Association Test'}, {'measure': 'Verbal memory score', 'timeFrame': '10 weeks', 'description': 'Stories of Wechsler Memory Scale Revised - WMS R'}, {'measure': 'Visual memory score', 'timeFrame': '10 weeks', 'description': 'Rey complex figure'}]}, 'conditionsModule': {'keywords': ['Hypertension', 'Cognition', 'Computerized Training', 'Cogmed'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Systemic arterial hypertension is a disease with high prevalence in several countries, including Brazil. Many studies have correlated hypertension with accelerated loss of cognitive function, especially executive functions. There is some evidence that working memory (WM) is compromised in these populations. However, some computerized training has been developed to rehabilitate the WM, and among them the investigators highlight the Cogmed. Thus, the aim of this study is to evaluate the effects of Cogmed training in the performance of WM and attention of hypertensive patients, as well as the impact of training in the structure and brain function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals of both genders, of any ethnicity\n* Signing the consent form\n* Access to computer with internet at home\n* Inexperienced to computerized cognitive training\n* Hypertensive pre-diagnosed\n* Basic schooling of four years\n* Cognitive impairment\n\nExclusion Criteria:\n\n* Marked functional limitation\n* Cognitive limitation or serious communication\n* Severe neurological and psychiatric diseases\n* Stroke history, head trauma or substance abuse'}, 'identificationModule': {'nctId': 'NCT02738034', 'briefTitle': 'Cogmed Training Effect in Hypertensive Patients With Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Cogmed Training Effect in Hypertensive Patients With Cognitive Impairment: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CogDoc2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adaptive training group', 'description': 'The intervention group will be composed of hypertensive participants with cognitive decline that will be submitted to the training program (Cogmed) for approximately 10 weeks. Across training, task difficulty was adjusted as a function of individual performance.', 'interventionNames': ['Other: Cogmed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active control Group', 'description': 'In the control group, hypertensive patient will be submitted to a set of online games available on the internet and previously determined. In this way, the control group will receive the same motivation, as well as will be engaged in computerized activities, in the same way as the experimental group. The difference is that these varied games do not provide any type of intense and adaptive training, at the same time as they do not stimulate any specific cognitive function.', 'interventionNames': ['Other: Cogmed']}], 'interventions': [{'name': 'Cogmed', 'type': 'OTHER', 'description': 'The Cogmed is computer software designed to train visuospatial and audio-verbal working memory, and other functions associated with working memory: attention, focus and impulsiveness. It has three versions adapted to different age groups: Cogmed for younger children, about 4-7 years, which are not yet so familiar with numbers and letters; Cogmed for children over 7 years and adolescents; and Cogmed for youth and adults over 18 years. In this study we will use the version for youth and adults over 18 years.', 'armGroupLabels': ['Active control Group', 'Adaptive training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Regina Silva Paradela', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'Regina Silva Paradela', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}